Glossary
The words on certificates, labels and library pages, in plain language.
- Amino acidThe science
One link in a peptide chain. The US National Human Genome Research Institute: “An amino acid is the fundamental molecule that serves as the building block for proteins. There are 20 different amino acids.”
Source: National Human Genome Research Institute (NIH), Talking Glossary, Amino Acids, last checked 29 October 2026
- Bacteriostatic waterHandling
Sterile water with a preservative added. One US label: “Bacteriostatic Water for Injection, USP is a sterile, nonpyrogenic preparation of water for injection containing 0.9% (9 mg/mL) or 1.1% (11 mg/mL) of benzyl alcohol added as a bacteriostatic preservative.”
Source: Hospira, Bacteriostatic Water for Injection, USP, label on DailyMed (revised 08/2019), last checked 29 October 2026
- BatchQuality
One production lot, with its own number. Health Canada’s manufacturing guide: “A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits.”
Source: Health Canada, Good manufacturing practices guide for drug products (GUI-0001), glossary; last checked 29 October 2026
- Certificate of analysisQuality
A testing report for one batch. ICH Q7, the international guide for active ingredients: “The Certificate should list each test performed in accordance with compendial or customer requirements, including the acceptance limits, and the numerical results obtained (if test results are numerical).”
Source: ICH Q7, s. 11.42; last checked 29 October 2026
- HPLCQuality
High-performance liquid chromatography, a chromatographic test. The European Medicines Agency: “Synthetic peptides are generally purified using chromatographic techniques” and “Purity is one of the most important critical quality attributes (CQAs) for synthetic peptides.”
Source: EMA, Guideline on the Development and Manufacture of Synthetic Peptides, s. 4.2.2 and s. 4.3.2; last checked 29 October 2026
- LyophilizedHandling
Freeze-dried. The US Food and Drug Administration: “Lyophilization or freeze drying is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase.” The European Medicines Agency: “Lyophilisation of synthetic peptides is considered common practice.”
Source: FDA, Guide to Inspections of Lyophilization of Parenterals (7/93); EMA, Guideline on the Development and Manufacture of Synthetic Peptides, s. 4.2.2; last checked 29 October 2026
- Mass spectrometryQuality
A test that measures a molecule’s mass. The European Medicines Agency: “Mass spectrometry (MS) is a powerful analytical tool for the structure elucidation of peptides.”
Source: EMA, Guideline on the Development and Manufacture of Synthetic Peptides, s. 4.3.1; last checked 29 October 2026
- Peptide bondThe science
The join between two amino acids. The US National Human Genome Research Institute: “A peptide is a short chain of amino acids (typically 2 to 50) linked by chemical bonds (called peptide bonds).” When the bond forms, a textbook explains: “One amino acid's carboxyl group and the incoming amino acid's amino group combine, releasing a water molecule.”
Source: National Human Genome Research Institute (NIH), Talking Glossary, Peptide; OpenStax Biology 2e, section 3.4 Proteins; last checked 29 October 2026
- Prescription drugThe rules
Under Canadian law, a drug that may only be sold as the Food and Drug Regulations allow. Health Canada: “In Canada, peptides are generally regulated as prescription drugs.”
Source: Health Canada, public advisory of 9 April 2026, last checked 4 October 2026
- ReconstitutionHandling
Adding a liquid to a freeze-dried powder so that it becomes a solution. One US label for bacteriostatic water describes that use: it is “indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug”.
Source: Hospira, Bacteriostatic Water for Injection, USP, label on DailyMed (revised 08/2019), last checked 29 October 2026
- Research use onlyThe rules
A label for material sold for laboratory research. Health Canada: “This type of labelling does not make these products legal or exempt from regulatory requirements.”
Source: Health Canada, public advisory of 9 April 2026, last checked 4 October 2026
- SequenceThe science
The order of amino acids in a chain, written in three-letter or one-letter codes. The international naming rules: “A one-letter code is much more concise, and is helpful in summarizing large amounts of data, in aligning and comparing homologous sequences, and in computer techniques for these processes.”
Source: IUPAC-IUB Joint Commission on Biochemical Nomenclature, Nomenclature and Symbolism for Amino Acids and Peptides, 3AA-20; last checked 29 October 2026